Analytical Method Development And Validation ...

Analytical Method Development And Validation of Teneligliptin Hydrobromide Hydrate Active Pharmaceutical Ingredient By Using GC

Author Name : Vuppala.S.R.B.M.Prahlad, V. Swetha

ABSTRACT

Teneligliptin hydrobromide hydrate is an Anti-Diabetic drug used in the treatment of Diabetes. In the proposed study an attempt is made for the method development  and validation of Teneligliptin hydrobromide hydrate  using  GC.

The chromatographic separation in GC was achieved with column DB-624 (30mts, 0.53mm,3 μm film thickness) and diluent as Dimethyl acetamide. The Carrier gas (Nitrogen) was pumped through the column with at a flow rate of 2.5psi.The Detector temperature was optimized as 250°C. The stressed samples were analysed using a Flame ionization  detector  for the product of Teneligliptin Hydro bromide Hydrate.

The method was validated for accuracy, precision, specificity, robustness, ruggedness,  detection and Quantitation limits, in accordance with ICH guidelines. Statistical analysis proved that the method was precise, reproducible, selective, specific, and accurate for analysis of Teneligliptin hydrobromide hydrate.